Melanoma Clinical Trial
An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread
Summary
The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.
Eligibility Criteria
For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
During dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen
During cohort expansion, subjects with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type
Subjects must have measurable disease
Subject must consent to provide previously collected tumor tissue and a tumor biopsy during screening.
At least 4 weeks since any previous treatment for cancer
Must be able to swallow pills or capsules
Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1
Exclusion Criteria:
Active or chronic autoimmune diseases
Uncontrolled or significant cardiovascular disease
History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS)
Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)
Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease
Active infection
Other protocol defined inclusion/exclusion criteria could apply
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There are 47 Locations for this study
Tucson Arizona, 85724, United States
La Jolla California, 92093, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Chicago Illinois, 60637, United States
Lutherville Maryland, 21093, United States
Detroit Michigan, 48201, United States
Saint Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
New York New York, 10016, United States
Cleveland Ohio, 44195, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37232, United States
North Sydney New South Wales, 2146, Australia
Sydney New South Wales, 2010, Australia
Westmead New South Wales, 2145, Australia
Brisbane Queensland, 4102, Australia
Clayton Victoria, 3168, Australia
Melbourne Victoria, 3000, Australia
Nedlands Western Australia, 6009, Australia
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Toronto Ontario, M5G 1, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H3T 1, Canada
Helsinki , 00180, Finland
Lille CEDEX , 59037, France
Lyon Cedex 08 , 69373, France
Marseille Cedex 5 , 13385, France
Nantes Cedex 01 , 44093, France
Paris , 75005, France
Toulouse , 31100, France
Villejuif , 94800, France
Essen , 45147, Germany
Heilbronn , 74078, Germany
Milano , 20132, Italy
Milano , 20133, Italy
Milano , 20141, Italy
Rozzano MI , 20089, Italy
Oslo , 0424, Norway
Warszawa Mazowieckie, 02-78, Poland
Barcelona , 08035, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Solna , 171 6, Sweden
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